MR Guided Focused Ultrasound vs Radiotherapy for Palliative Pain Tx in Bone Metastases

Not Recruiting

Trial ID: NCT05250687

Purpose

This is a prospective, single-center, randomized study directly comparing outcomes after MR guided high intensity focused ultrasound (MR HIFU) or external beam radiation therapy (EBRT) treatment of painful bone metastases.

Official Title

MR Guided Focused Ultrasound Versus Radiotherapy for Palliative Pain Treatment in Patients With Bone Metastases

Stanford Investigator(s)

Pejman Ghanouni, MD, PhD
Pejman Ghanouni, MD, PhD

Associate Professor of Radiology (General Radiology) and, by courtesy, of Neurosurgery, of Obstetrics and Gynecology and of Urology

Lucas Kas Vitzthum, MD
Lucas Kas Vitzthum, MD

Clinical Associate Professor, Radiation Oncology - Radiation Therapy

Eligibility


Inclusion Criteria:

   1. Age ≥ 18 years

   2. Painful metastatic bone lesions, with NRS > 4 documented at screening visit

   3. Pain from target lesion is distinguishable from other lesions*

   4. Target lesion lovation is accessible for MR-HIFU and EBRT**

   5. Target lesion is visible om MR or CT imaging obtained < 3 months prior to screening,
   with a maximum diameter of 8 cm.

   6. Reasonable performance score (KPS > 50% or ECOG <3)

   7. Life expectancy > 3 months as determined by the study PI or referring oncologist

   8. Ability to understand and the willingness to personally sign the written IRB-approved
   informed consent document

      - Solitary painful metastatic bone lesion or multiple metastatic lesions with one
      predominantly painful target lesion (≥2 points higher pain score than other
      lesions).

         - e.g.: Extremities, pelvis (os pubis, os ilium, os ischium, sacrum,
         acetabulum), shoulders, in selected cases ribs and sternum

Exclusion Criteria:

   1. Previous surgery, radiation, HIFU, or other local therapy on the target location

   2. Neurological symptoms due to nerve involvement of target lesion

   3. Need for surgery of targeted location due to (impending) pathological fracture

   4. Unavoidable critical structures or dense tissues in target area*

   5. Curative intention of treatment plan

   6. Patients with contraindication for MR imaging such as implanted metallic devices that
   are not MRI - safe, size limitations, claustrophobia, etc.

   7. Patients with known intolerance or allergy to MR contrast agent (gadolinium chelates)
   including advanced kidney disease (GFR <30mL/min/1.73 m^2) or on dialysis

   8. Pregnant and nursing patients will be excluded from the study because of a
   contraindication to administering MRI contrast agents to these patients

   9. Patients unable to receive general anesthesia, as determinded by anesthesiologist,
   study PI or referring oncologist

10. Individuals who are not able or willing to tolerate the required prolonged stationary
   position during treatment (can be up to 4 hrs of total table time) via self report

11. Participant enrolled in another clinical interventional study related to bone
   metastases treatment or pain relief treatment

12. Clinically relevant medical history or physical findings that could interfere with the
   patient's safety as judged by the treating physician

      - as judged by the operator. e.g.: nerve bundles, skin, extensive scarring,
      non-targeted bones, air (e.g. hollow viscera), (external) fixation device

Intervention(s):

procedure: MR- High intensity focused ultrasound

radiation: External beam radiotherapy

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Brittney Williams
650-497-8588

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